Since the Falsified Medicines Directive (Directive 2011/62/EU, with delegated regulation 2016/161) came into force in February 2019, most EU markets have required prescription medicines to carry a unique identifier plus a tamper-evident device, and to be connected to the European Medicines Verification System (EMVS). This is the same internal checklist we hand to manufacturers — the operational view, broken into twelve concrete items.
Serialization & encoding
- GTIN allocated and registered. Each SKU carries a unique GTIN-14 obtained via GS1.
- Serial number generation. Each saleable unit gets a ≤20-character, unique, non-guessable serial.
- Batch and expiry. Batch ID and expiry date encoded into the 2D Data Matrix (GS1 AIs 10 and 17).
- NHRN where applicable. Germany's PZN, France's CIP, Italy's AIC, and other national codes correctly included.
Packaging line integration
- L1–L5 architecture in place. Data comms from line level (L1) up to enterprise level (L5) is complete and auditable.
- Aggregation. Parent–child relationships between cases, bundles, and saleable units are correctly recorded.
- End-of-line verification. OCR plus vision checks confirm the Data Matrix is readable on every unit before shipment.
EMVS connectivity
- OBP connectivity. SOAP/REST connection to your home country's NMVO or directly to the European Medicines Verification Hub (OBP) is tested in production.
- Full event coverage. Commission, decommission, withdraw, reactivate, and export events are all reportable across the full lifecycle.
- Error-handling SLA. EMVS rejections, duplicates, and inconsistent responses have a documented investigation and rollback path.
Audit and retention
- 5-year audit log retention. Every reported event, every EMVS response, every reactivation carries a signed timestamp.
- Quarterly drills. Simulated EMVS outages, serial number collisions, and recall scenarios run quarterly with measured RPO/RTO.
The two most common gaps
Across APAC contract manufacturers, the two gaps we see most often are: (a) aggregation data missing parent–child links to cases, and (b) returns workflows that lack controls against unsafe reactivation. Both surface immediately during routine EMA inspections.
How VeriTag relates to FMD
Veridian VeriTag complements FMD — it does not replace it. FMD answers the question "is this unbroken outer pack legitimate in the system?" VeriTag answers the question "is this specific item in the consumer's hand actually what it claims to be?" — even when the outer pack is legitimate and unbroken. Together they close the last-mile gap that FMD by itself cannot reach.
FMD anchors verification at the moment of dispense. NFC verification carries that same mathematical rigor through to the moment of use.
A PDF copy of this checklist is available on request via our compliance contact form.